UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034875
Receipt No. R000039433
Scientific Title Effects of Guar Gum Decompostion Producton fecal microbiota and other factors in hyperbaric environment
Date of disclosure of the study information 2019/01/01
Last modified on 2019/05/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of Guar Gum Decompostion Producton fecal microbiota and other factors in hyperbaric environment
Acronym Effects of Guar Gum Decompostion Producton fecal microbiota and other factors in hyperbaric environment
Scientific Title Effects of Guar Gum Decompostion Producton fecal microbiota and other factors in hyperbaric environment
Scientific Title:Acronym Effects of Guar Gum Decompostion Producton fecal microbiota and other factors in hyperbaric environment
Region
Japan

Condition
Condition Alteration of fecal microbiota
dysbaric osteonecrosis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Orthopedics
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In past experiment, it was confirmed that the intestinal microbial flora changes under a stress environment of hyperbaric environment.
The experiment results suggested that intestinal environment was deteriorated while effective in the formation of the intestinal immune system.
On the other hand, guar gum decomposition products are recognized as having an effect to improve the intestinal environment.
We observe the alteration of fecal microbiota when ingesting guar gum breakdown products under hyperbaric environment and make it use for future treatment.
Dysbaric osteonecrosis has been reported in deep diving with very low frequency. By observing altrations of bone metabolism markers at hyperbaric environment, we will aim to elucidate the mechanism of decompressive osteonecrosis and to prevent it.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes First, we will observe alteration of fecal microbiota (Species) before intake of guar gum and one week after intake of guar guam decomposition products.We investigate alteration of fecal microbiota in 0.7 MPa environmentand and during decompression.
Osteometabolism markers one week after intake of guar guam decomposition products.We will make evaluation of osteometabolism markers in the same way.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The subjects are made to intake guar gum decomposition products from 1 week before exposure to hyperbaric condition(0.7 MPa) to the end of exposure to hyperbaric condition.
Interventions/Control_2 The subjects are exposed to hyperbaric condition(0.7 MPa).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
55 years-old >
Gender Male
Key inclusion criteria Healthy male divers who did not refuse cooperation of research
Key exclusion criteria People with a serious disease history
Target sample size 12

Research contact person
Last name of lead principal investigator
1st name Morihiko
Middle name
Last name Oya
Organization Maritime Self-Defense Force Umdersea Medical Centor
Division name Experimental Department
Zip code 237-0071
Address Tauraminatomachi, Yokosuka, Kanagawa, Japan
TEL 046-822-3500
Email umc-d1@inet.msdf.mod.go.jp

Public contact
1st name of contact person
1st name Morihiko
Middle name
Last name Oya
Organization Maritime Self-Defense Force Umdersea Medical Centor
Division name Experimental Department
Zip code 237-0071
Address Tauraminatomachi, Yokosuka, Kanagawa, Japan
TEL 046-822-3500
Homepage URL
Email umc-d1@inet.msdf.mod.go.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Funding Source
Organization National Defense Medical College
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Maritime Self-Defense Force Umdersea Medical Centor
Address Tauraminatomachi, Yokosuka, Kanagawa, Japan
Tel 046-822-3500
Email umc-d1@inet.msdf.mod.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 17
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 13 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039433

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.